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Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users (TEXTR34)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343654
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : February 15, 2018
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia

Brief Summary:

The investigators will develop and test the feasibility and promise of a combined HIV adherence assessment and intervention application for rural drug users using an available, familiar technology whose reach will grow exponentially: text messaging via mobile phones. By 2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration projected by 2013. While technology adoption is often slower in under-served communities, the trend is different with mobile phone technology. African-Americans are using more mobile phone minutes per capita and increasing their use at a higher rate compared with other ethnic groups. This technology has great potential to reduce health disparities. In this project, the investigators will develop and test the feasibility and promise of a text messaging application and system using Ecological Momentary Assessment methods to detect nonadherence and drug use and immediately intervene to improve HIV treatment adherence in drug users living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a project in the Stage Model of Behavioral Therapy Development that will develop novel interventions and methods, and generate preliminary estimates of effect sizes that will determine whether a larger clinical trial with extended follow-up and cost-effectiveness evaluation is warranted.

The specific aims of this project are:

  1. To identify assessment and intervention features relevant to the adherence barriers and drug use patterns of rural and non-urban HIV+ drug users using formative methods including:

    • structured interviews and focus groups to identify specific barriers to adherence and engagement in care and needs related to drug craving and drug use that should be addressed by the intervention
    • iterative usability testing of components and drafts of the intervention
  2. To create a text messaging mobile phone application and system (Treatment Extension by Texting, Text) to assess and improve HIV treatment adherence and drug use in real time

    --Text will be built upon a piloted unidirectional personalized text phone application and system, STeM, and will include pre- and post-programming usability testing

  3. To test the feasibility and promise of the assessment and intervention tool in a randomized pilot trial of rural HIV+ drug users with detectable viral load (VL) comparing Text to usual care

    • Feasibility: Identify recruitment rates, consent rates, participant flow, completion rates, and variance of key covariates and outcome variables
    • Promise: determine point estimates and the precision of effects for primary and secondary adherence outcomes including pharmacy refills and unannounced pill counts (medication adherence), missed visit percentage (treatment engagement), VL, and drug craving and drug use.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Text messaging plus EMA Behavioral: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT of a Text Messaging Adherence Assessment & Intervention Tool for Rural HIV+ Drug Users
Study Start Date : May 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
Experimental: Text messaging
Participants randomized to this arm will receive a mobile phone if needed, and the 12 week personalized text messaging/EMA intervention
Behavioral: Text messaging plus EMA
Personalized, tailored text messaging to prompt medication adherence, with EMA random queries about nonadherence and drug use, and two-way messaging for participants to report critical events

Active Comparator: Treatment as usual
Participants randomized to this arm will receive treatment as usual in the ID clinics and in the communities for nonadherence and drug use problems
Behavioral: Treatment as usual
usual care in one of the three participating ID clinics, along with usual care (if any) in the community for problematic drug and alcohol use

Primary Outcome Measures :
  1. Missed Visit Proportion (MVP) [ Time Frame: 6 months ]
    The primary outcome measure for ADHERENCE is missed visit proportion (MVP) across a 6 month follow-up period, used to derive the sample size for this stage 1 RCT. The primary outcome measure for DRUG USE is a Timeline Follow-back to gather 90 day retrospective reports of daily drug use.

Secondary Outcome Measures :
  1. pharmacy refill data [ Time Frame: 6 months ]
    Secondary outcome measures for adherence will be unannounced telephone pill counts and pharmacy refill data; these will be assessed and used to plan a larger, more definitive study, if the intervention shows promise. Pharmacy compliance can be measured directly in the large subset of patients who fill their prescription through the Virginia ADAP Program. Unannounced pill counts conducted by phone can be assessed for all participants and used to measure medication adherence.

  2. Secondary: text messaged adherence and drug use data [ Time Frame: during 12 week intervention period ]
    We will have daily data from participants' text messages about their adherence behavior. Comparing texts sent by participants about adherence to TLFB will allow us to test the level of agreement about adherence by two distinct measures, one (TLFB) with known properties. Differences in the magnitude and direction of the effect of the intervention for different outcomes will help us choose an outcome for the larger trial, and may shed light on the particular aspects of behavior that the text messaging tool can influence.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 or older
  • has a detectable viral load
  • reports use of at least one illicit drug in last 30 days
  • requires ART
  • able to receive mobile phone service at home address

Exclusion Criteria:

  • lack of English proficiency
  • planning to move out of area in the next six months
  • inability to provide consent.

Note regarding "inability to provide consent": Traditionally, some patients with HIV whom we evaluate for potential participation in research studies are not able to provide informed consent, either due to significant cognitive decline, or their designation of someone else as their legal proxy. When this occurs, we do not offer them study participation because legally, they are unable to consent, even if currently, their cognitive capacities seem intact. We have generally assessed this through a series of branching questions to determine their legal and cognitive capacity for consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343654

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United States, Virginia
UVA Infectious Diseases Clinic
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Karen S Ingersoll, Ph.D. University of Virginia
Publications of Results:
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Responsible Party: Karen Ingersoll, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia Identifier: NCT01343654    
Other Study ID Numbers: 15475
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karen Ingersoll, University of Virginia:
HIV medication adherence
drug use
nonadherence to HIV medications
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases